Axios recallZ-0774-2021 · Boston Scientific Corporation · initiated Dec 1, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
FDA root cause category: Process control
What the company is doing
Boston Scientific issued customer notification letters to consignees via Federal Express Priority Overnight mail on December 1, 2020. The letter states reason for recall, health risk and action to take: Cease further distribution or use of any remaining product affected by this removal immediately. Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Reply Verification Tracking Form the quantity of units from each lot/batch that you will be returning. If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth of this removal is to the end user level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital or facility within your network, please ensure that this notification is forwarded to them. Your local Sales Representative can answer any questions that you may have regarding this notification.
Recall details
- Recall number
- Z-0774-2021
- Status
- Terminated
- Initiated by the company
- Dec 1, 2020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 32 units
- Product code
- PCU
- FDA submissions
- K181905
- Distribution
- US Nationwide distribution - Foreign: TBD.
Product description
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Code information (models, lots, serial numbers)
Lot Number: 26152465, 26152466, 26152467 Exp. Date: 10/8/2022 GTIN: 08714729904595
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Axios™ M00553650Boston Scientific Corporation · pancreatic stent, covered, metallic, removable2 recalls5 deaths338 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 86909).
- Z-0773-2021 · TerminatedAXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon…
- Z-0775-2021 · TerminatedAXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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